Job Title: Senior Design Assurance Engineer
Location: San Francisco, CA
Type: Full-Time (on-site)
Coherence Neuro is a highly interdisciplinary neurotechnology company solving some of the most challenging biological and medical problems that remain unmet. Our goal is to develop technologies that significantly increase the quality and length of life for those with debilitating and deadly cancers in the brain and body. We are backed by the best global venture capital firms, and are scaling our team across multiple sites to bring our products to those who need it as quickly and safely as possible. If you're driven to push the boundaries of engineering and science and want to help build something that genuinely changes lives, we want to hear from you. We value diversity and encourage applicants from all backgrounds to join us in our mission. Learn about our team here!
We are seeking a driven and meticulous Senior Design Assurance Engineer to join the Quality team and play a key role in bringing our novel implantable neurotechnology safely to first-in-human studies. The successful candidate will own the risk management and design control processes that ensure our device is safe, effective, and submission-ready, working closely with engineers, neuroscientists, and suppliers throughout the product development lifecycle.
Key Responsibilities
- Develop and maintain design & development files, medical device files, and design control documentation per ISO 13485:2016 and 21 CFR Part 820 (QMSR).
- Lead product risk management activities in accordance with ISO 14971, including hazard identification, FMEAs, risk-benefit analysis, residual risk evaluation. Prepare required deliverables and document the risk management outcomes, control measures, residual risks in reports. Maintain risk management file for the life of the device.
- Lead Design Assurance reviews of technical documentation with the engineering team, develop test methods and test plans, and prepare design verification and validation test deliverables.
- Interpret and apply applicable compliance standards and regulations to develop verification testing plans, establish acceptance criteria, validate test methods and define statistical sampling rationales.
- Facilitate and document design reviews, ensuring compliance and end-to-end traceability from user needs and requirements through verified design outputs.
- Support maintenance of the QMS, including supplier qualification, change control, document management.
- Support the preparation of IDE and PMA submission packages
Required Qualifications and Skills
- B.S. in Biomedical, Electrical, Mechanical Engineering, or related engineering discipline. Advanced degree preferred.
- 5+ years of overall experience in the medical device industry, including at least 3 years in a design assurance, quality engineering, or R&D quality role.
- Design assurance experience with Class III or active implantable medical devices.
- Working knowledge of medical device design controls, quality system regulations, risk management, and electrical safety standards, including ISO 13485, 21 CFR Part 820, ISO 14971, ISO 14708-1, IEC 62304, IEC 62366-1, and IEC 60601-1.
- Experience supporting verification and validation activities for medical device hardware or electromechanical systems.